Zinbryta ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎4

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002820-10-DE
(EUCTR)
26/06/201708/11/2016Efficacy and Safety of Daclizumab in Participants with RRMS Switching from NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) Remitting-Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Zinbryta
Product Name: Daclizumab
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: DAC HYP
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Canada;Germany;Italy;United Kingdom
2EUCTR2016-002820-10-IT
(EUCTR)
31/03/201713/01/2021Efficacy and Safety of Daclizumab in Participants with RRMS Switching from NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) - Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab Remitting-Relapsing Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Zinbryta
Product Name: Daclizumab
Product Code: BIIB019
INN or Proposed INN: DACLIZUMAB
Other descriptive name: DAC HYP
BIOGEN IDEC RESEARCH LIMITEDNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Canada;Denmark;Germany;United Kingdom;Italy
3EUCTR2016-002820-10-GB
(EUCTR)
13/03/201708/11/2016Efficacy and Safety of Daclizumab in Participants with RRMS Switching from NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) - 205MS305_Biogen Remitting-Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Zinbryta
Product Name: Zinbryta
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: DAC HYP
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Canada;Denmark;Germany;Italy;United Kingdom
4EUCTR2012-003176-39-CZ
(EUCTR)
16/04/201307/02/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND Relapsing-remitting Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Zinbryta
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden